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Clinical Toxicology

3,040 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) (K003845)Alfa Scientific Designs, Inc.2001-05-29
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST (K003647)Alfa Scientific Designs, Inc.2001-05-29
INSTANT-VIEW METHADONE URINE CASSETTE TEST (K010015)Alfa Scientific Designs, Inc.2001-05-29
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) (K003879)Alfa Scientific Designs, Inc.2001-05-29
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY (K010177)Sun Biomedical Laboratories, Inc.2001-05-17
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (K011347)Syva Co.2001-05-17
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 (K011300)Syva Co., Dade Behring, Inc.2001-05-17
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 (K011306)Syva Co., Dade Behring, Inc.2001-05-16
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 (K011289)Syva Co., Dade Behring, Inc.2001-05-15
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (K011166)Syva Co., Dade Behring, Inc.2001-05-10
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (K011163)Syva Co., Dade Behring, Inc.2001-05-10
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 (K011164)Syva Co., Dade Behring, Inc.2001-05-10
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY (K011162)Syva Co., Dade Behring, Inc.2001-05-02
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 (K010960)Syva Co., Dade Behring, Inc.2001-04-26
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 (K010962)Syva Co., Dade Behring, Inc.2001-04-26
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 (K010934)Syva Co., Dade Behring, Inc.2001-04-20
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS (K003809)Rapid Diagnostics, Inc.2001-04-20
EMIT 2000 GENTAMICIN PLUS ASSAY (K010984)Syva Co., Dade Behring, Inc.2001-04-20
LIVESURE COCAINE SCREEN TEST (K010967)Pan Probe Biotech, Inc.2001-04-17
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 (K010812)Syva Co., Dade Behring, Inc.2001-04-13
VERDICT -II BAR; VERDICT -II BZO (K010959)Medtox Diagnostics, Inc.2001-04-13
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 (K010814)Syva Co., Dade Behring, Inc.2001-04-13
LIVESURE MORPHINE SCREEN TEST (K011011)Pan Probe Biotech, Inc.2001-04-13
AT WORK DRUG TEST, MODEL 9147T AWT (K010836)Phamatech2001-04-11
AT WORK DRUG TEST, MODEL 9177T AWT (K010833)Phamatech2001-04-11
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO (K010564)Medtox Diagnostics, Inc.2001-04-05
VERDICT -II BAR/BZO (K010561)Medtox Diagnostics, Inc.2001-04-05
AT HOME DRUG TEST, MODEL 9073 T (K010650)Phamatech2001-03-30
AT HOME DRUG TEST, MODEL 9063 T (K010645)Phamatech2001-03-30
ESCREEN SYSTEM (K003352)Escreen, Inc.2001-03-20
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) (K003557)ACON Laboratories, Inc.2001-03-15
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 (K004034)Branan Medical Corp.2001-03-08
COBAS INTEGRA AMPHETAMINES (K003865)Roche Diagnostics Corp.2001-02-28
PROFILE II ER (K010138)Medtox Diagnostics, Inc.2001-02-14
LIVESURE THC SCREEN TEST (K010001)Pan Probe Biotech, Inc.2001-02-05
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (K002375)OraSure Technologies, Inc.2001-01-26
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS (K003341)Syva Co., Dade Behring, Inc.2001-01-22
ADVANTAGE THC/COCAINE TEST (K003708)Advantage Diagnostics Corp.2001-01-22
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (K003583)Trace America, Inc.2001-01-17
PROFILE-ER (K002331)Medtox Diagnostics, Inc.2001-01-17
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC (K003687)Medtox Diagnostics, Inc.2000-12-22
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR (K000851)Psychemedics Corp.2000-12-11
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (K001976)OraSure Technologies, Inc.2000-12-06
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A (K003209)Dade Behring, Inc.2000-12-05
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (K002010)OraSure Technologies, Inc.2000-11-29
FIRST CHECK HOME DRUG TEST PANEL 4 (K993852)Worldwide Medical Corp.2000-11-29
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST (K002268)Branan Medical Corporation2000-11-27
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST (K002263)Branan Medical Corp.2000-11-27
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST (K002264)Branan Medical Corporation2000-11-27
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST (K002342)Branan Medical Corporation2000-11-27
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST (K002265)Branan Medical Corporation2000-11-27
BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST (K002337)Branan Medical Corporation2000-11-22
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST (K002266)Branan Medical Corporation2000-11-22
BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D (K002417)Branan Medical Corporation2000-11-22
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST (K002587)Branan Medical Corporation2000-11-22
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D (K002418)Branan Medical Corporation2000-11-22
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL (K002447)American Bio Medica Corp.2000-11-16
CARESIDE CHOLINESTERASE (K002792)Careside, Inc.2000-11-08
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL (K002551)Dade Behring, Inc.2000-10-11
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL (K002974)Dade Behring, Inc.2000-10-11
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST (K994403)Alfa Scientific Designs, Inc.2000-08-14
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST (K994406)Alfa Scientific Designs, Inc.2000-08-14
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST (K994395)Alfa Scientific Designs, Inc.2000-08-07
PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST (K001126)Alatex Scientific, Inc.2000-08-07
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST (K994399)Alfa Scientific Designs, Inc.2000-08-04
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST (K994400)Alfa Scientific Designs, Inc.2000-08-04
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST (K994398)Alfa Scientific Designs, Inc.2000-07-27
ONTRAK TESTCUP 501, MODEL 3016633 (K001421)Roche Diagnostics Corp.2000-07-12
ONTRAK TESTCUP PRO-5, MODEL 1986678 (K001356)Roche Diagnostics Corp.2000-07-10
INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST (K994409)Alfa Scientific Designs, Inc.2000-07-10
INSTANT-VIEW MORPHINE URINE CASSETTE TEST (K994404)Alfa Scientific Designs, Inc.2000-07-05
ONTRAK TESTCUP 502, MODEL 3016641 (K001417)Roche Diagnostics Corp.2000-06-29
ADVIA IMS (K001344)Bayer Corp.2000-06-26
FIRST CHECK HOME DRUG TEST PANEL 2 (K994139)Worldwide Medical Corp.2000-06-23
FIRST CHECK HOME DRUG TEST (THC) (K993663)Worldwide Medical Corp.2000-06-23
FIRST CHECK HOME DRUG TEST PANEL 3 (K994138)Worldwide Medical Corp.2000-06-23
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST (K994410)Alfa Scientific Designs, Inc.2000-06-21
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 (K001286)Diagnostic Chemicals , Ltd.2000-06-20
ADVANTAGE THC TEST (K001567)Advantage Diagnostics Corp.2000-06-19
CEDIA DAU 6-ACETYLMORPHINE ASSAY (K001178)Microgenics Corp.2000-06-09
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST (K994405)Alfa Scientific Designs, Inc.2000-06-02
QUICKSCREEN PRO DRUG CUP, MODEL 9195X (K001397)Phamatech2000-05-26
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (K000903)Bayer Corp.2000-05-18
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. (K001225)Princeton BioMeditech Corp.2000-05-17
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA (K001197)OraSure Technologies, Inc.2000-05-11
SYNCHRON SYSTEMS AMPHETAMINE REAGENT (K000606)Beckman Coulter, Inc.2000-05-05
CEDIA DAU AMPHASSURE ASSAY (K994380)Microgenics Corp.2000-05-02
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 (K000096)Roche Diagnostics Corp.2000-04-26
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST (K000452)Drug Detection Devices, Ltd.2000-04-24
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST (K000400)Drug Detection Devices, Ltd.2000-04-18
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST (K000522)Drug Detection Devices, Ltd.2000-04-18
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A (K000458)Dade Behring, Inc.2000-04-17
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A (K000467)Dade Behring, Inc.2000-04-14
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT (K000494)Beckman Coulter, Inc.2000-04-14
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A (K000464)Dade Behring, Inc.2000-04-14
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A (K000460)Dade Behring, Inc.2000-04-14
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 (K994164)Roche Diagnostics Corp.2000-04-13
SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST (K000350)Drug Detection Devices, Ltd.2000-04-11
REDI-SCREEN (K000979)Redwood Biotech, Inc.2000-04-10
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (K000410)Beckman Coulter, Inc.2000-04-10
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